Clin2
NCT05886517Possibly a fitRecruiting

Transcatheter aortic valve in patients too high-risk for surgery

Aortic Stenosis

Part of Heart & circulation clinical trials.

This trial looks at placing a new aortic valve through the groin (transfemoral) without needing on-site heart surgery for people who are considered very high risk for standard open-heart valve surgery. It aims to measure early outcomes to see how safe and effective this approach is for frail or complex patients.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
200 people
Ages
75 years to 120 years
Study type
Interventional

Who can take part

  • You have symptomatic aortic valve narrowing (aortic stenosis) with symptoms that are at least moderate (NYHA class II or higher).
  • Your heart ultrasound shows severe valve narrowing (for example, mean pressure gradient over 40 mmHg or valve area under 0.8 cm²).
  • You are age 75 or older.
  • A specialist team has judged you to be at prohibitive or very high surgical risk, based on standard risk scores or serious related problems (such as porcelain aorta, hostile chest, frailty, severe lung pressure, severe right-heart weakness, or severe liver disease).
  • You can have the valve procedure through the femoral (groin) artery.
  • You agree to participate by signing informed consent.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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